Stealth BioTherapeutics Receives Orphan Drug Designation from ...

The trial is evaluating two doses of elamipretide in patients with Friedreich's ataxia to assess safety, visual function, and cardiac function.

We believe our lead product candidate, elamipretide, has the potential to treat ophthalmic diseases entailing mitochondrial dysfunction, such as ...

Stealth BioTherapeutics Receives Orphan Drug Designation from ...

The European Medicines Agency (EMA) has granted orphan drug designation (ODD) for elamipretide for the treatment of myopathic mitochondrial DNA depletion ...

Stealth BioTherapeutics Announces SBT-272 Data Updates and ...

“We are pleased to receive orphan drug designation from FDA for SBT-272 for the treatment of ALS, underscoring the urgent need for innovative ...

Stealth Clinches Orphan Drug Designation in DMD - BioSpace

Stealth BioTherapeutics has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for elamipretide.

Stealth BioTherapeutics Receives Orphan Drug Designation from ...

Stealth BioTherapeutics Receives Orphan Drug Designation from the European Medicines Agency for Elamipretide for the Treatment of Myopathic ...

Stealth Biotherapeutics Announces FDA Acceptance of New Drug ...

Elamipretide received Fast Track Designation in 2017, Orphan Drug Designation in 2018 and Rare Pediatric Disease Designation in 2020. “We ...

Search Orphan Drug Designations and Approvals - FDA

03/22/2018 · Treatment of Barth syndrome · Designated · Not FDA Approved for Orphan Indication · Stealth Biotherapeutics, Inc. 140 Kendrick Street Building C-West

Stealth Biotherapeutics' SBT-272 Earns Orphan Drug Status for ALS

Investigational treatment SBT-272, by Stealth Biotherapeutics, appears safe in Phase 1 testing, receiving orphan drug status as ALS therapy.

Stealth BioTherapeutics Receives Orphan Drug Designation from ...

Stealth BioTherapeutics Receives Orphan Drug Designation from FDA for Elamipretide for Treatment of Duchenne Muscular Dystrophy.

STEALTH BIOTHERAPEUTICS' BARTH SYNDROME NDA ...

The FDA's decision to grant Priority Review designation follows its March 29, 2024 filing decision in which the FDA assigned a standard review ...

Stealth Bio's Elamipretide Gets Orphan Drug Designation From FDA ...

(RTTNews) - Stealth BioTherapeutics Corp. (MITO) said on Monday that its drug candidate Elamipretide has been granted orphan drug ...

Stealth receives orphan drug designation for elamipretide to treat DMD

Stealth BioTherapeutics has received Orphan Drug Designation from the US FDA to treat Duchenne muscular dystrophy (DMD) patients.

FDA Grants Orphan Drug Designation to Stealth BioTherapeutics ...

Elamipretide, which treats muscle weakness caused by mitochondrial disease, has received FDA Orphan Drug Designation.

FDA Grants Orphan Drug Designation to Elamipretide for DMD

Stealth BioTherapeutics receives Orphan Drug designation from FDA for elamipretide for treatment of Duchenne muscular dystrophy. News release.

Stealth BioTherapeutics Receives Orphan Drug Designation from ...

Pre-IND meeting request granted by FDA's Division of Neurology IBOSTON, May 12, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), ...

Stealth BioTherapeutics Announces Positive Vote from FDA ...

If Approved, Elamipretide Would Be the First Therapy for ... Orphan Drug Designation from the EMA for the treatment of Barth syndrome.

Stealth BioTherapeutics Shares Rally following FDA Orphan Drug ...

Stealth BioTherapeutics Corp (NASDAQ: MITO) received Orphan Drug Designation to Elamipretide from the United States Food and Drug ...

Stealth BioTherapeutics Receives Orphan Drug Designation from ...

Excerpt from the Press Release: BOSTON, May 12, 2022 /PRNewswire/ — Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology ...

Elamipretide Clinical Studies and Trials - Stealth BioTherapeutics

We have received Fast Track and Orphan Drug designation from the FDA for the development of elamipretide in this indication. The U.S. Food and Drug ...